Pneumonia, or an inflammation of the lungs, is a leading cause of morbidity and mortality worldwide. In 2002, there were 451 million lower respiratory infections reported to the World Health Organization. Worldwide, pneumonia accounts for nearly 30% of all deaths in children under the age of five, killing more children than AIDS, malaria, and measles combined. In the United States, there were an estimated 1.4 million hospitalizations and 59,000 deaths due to pneumonia in 2002. Pneumonia can be caused by a variety of bacterial and viral pathogens, including streptococcus pneumoniae, mycoplasma tuberculosis, influenza viruses, respiratory syncytial virus, parainfluenza, adenovirus, rhinovirus, human bocavirus, influenza, Mycoplasma pneumoniae, hantavirus, and cytomegalovirus.
To treat this condition appropriately it is necessary to properly identify the pathogen in the lower airway. This can be done by checking for the presence of the pathogen, virus, bacteria or fungus, in the lung, i.e. alveoli and/or bronchioles. Obtaining a sample from the lung and confirming the etiology of pneumonia has proven difficult. For example, in the case of one of the leading causes of pneumonia, streptococcus pneumonia, as much as 70% of healthy people carry pneumococcus in their upper respiratory system. This makes it difficult with the usual method of specimen collection, a sputum specimen, to confidently determine if a positive detection for S. Pneumoniae indicates carriage or the cause of pneumonia. A sputum specimen is collected after passing through the upper respiratory tract and mouth and is, therefore, contaminated with upper respiratory tract organisms. More invasive techniques including bronchial lavage, laparoscopic alveolar biopsy, or pleural tap do indicate presence of an organism in the lung but carry greater risk to the patient and are costly and painful.
An easy to obtain sample of material from the diseased lung would greatly improve a physician's ability to diagnose and treat pneumonia. A sample of material from lung alveoli and bronchioles is also beneficial in various other situations such as determining the presence and concentration of alcohol in the blood stream and diagnosing disease processes such as lung cancer.
Accurate diagnosis of pneumonia is still a major problem and the field is innovating toward complex devices with multiple valves and chambers. There is an unmet need for a simple device for collecting a sufficient sample of lower airway material not contaminated by upper airway material for accurate detection clinical of pneumonia. Thus, there exists a need for a simple device and process for collection of lower respiratory air such as lung aerosols while minimizing or eliminating contaminating upper respiratory tract air from the sample. There further exists a need for a device that can collect materials such as pathogenic organisms from lower respiratory tract air without significant contamination from similar or identical organisms in the upper respiratory tract.